Following Suit: Transvaginal Mesh Lawsuit Update

Austin, TXNationwide, thousands of transvaginal mesh (TVM) lawsuits are being settled, thousands more are pending in federal courts and countless TVM complaints are still being filed against the mesh manufacturers. According to court docket records, many vaginal mesh lawsuits are being settled out of court, with American Medical Systems (AMS) taking the lead.

“It’s good news that vaginal mesh lawsuits are being settled out of court more often. It demonstrates that even though the mesh maker does not admit to wrongdoing, they are stepping up to bat to rectify the damage they have caused to millions of women,” says Bobby Lee, a transvaginal mesh injury lawyer. Attorneys believe this action by AMS is good news for all TVM plaintiffs: they are hopeful that medical mesh manufacturers such as those below will follow AMS’ lead.

American Medical Services (AMS) transvaginal mesh litigation

In April 2014, Endo Pharmaceuticals Holdings Inc. agreed to pay $830 million to settle about 20,000 AMS vaginal mesh cases, which averages about $40,000 per case. Women who suffered more serious complications and required extensive surgery to attempt to remove the sling may receive more. Settlements are expected to take place in 2015. (Endo bought AMS in 2011, including its lawsuits.)

The Endo agreement to settle was announced after the company reported that it faced close to 22,000 lawsuits as of February 2014. Most of the lawsuits are in multidistrict litigation and are overseen by the U.S. District Court for the Southern District of West Virginia.

AMS had already settled a group of lawsuits for $54.5 million in 2013. During that time, the company also set aside $520 million for legal costs. However, that figure has been raised to $1.1 billion to cover all costs associated with transvaginal mesh litigation.

C.R. Bard Avaulta transvaginal mesh

C.R. Bard receives pelvic mesh products from Covidien PLC, a medical device manufacturer named in litigation along with Bard. According to a recent United States Securities and Exchange Commission (SEC) filing, “Covidien is indemnifying that manufacturer on certain claims.” As told to Reuters, Covidien recorded a pre-tax charge of about $180 million for the third quarter, related to litigation against some manufacturers of pelvic mesh products.

“This reservation of funds is encouraging,” said attorney Rochelle Rottenstein, of the Rottenstein Law Group. “It could suggest that claims by victims against Bard and Covidien might be settled sooner rather than later.”

About 9,000 of Bard’s Avaulta transvaginal mesh lawsuits are currently pending in a federal multidistrict litigation (MDL 2187) centralized in the Southern District of West Virginia with Judge Joseph R. Goodwin presiding. (Judge Goodwin is also presiding in a number of similar transvaginal mesh cases against the manufacturers of other transvaginal mesh devices.)

According to an Order dated July 2, 2014, the Court will hear Oral Arguments on a Plaintiffs Motion to Amend Pre-Trial Order No. 121 (Stipulated Evidence Preservation Protocol for Potential Trial Selection Cases) on Wednesday, July 9.

Three Bard Avaulta bellwether trials began in July 2013. The first bellwether (a trial that is used to help both plaintiff and defendant to gauge jury reaction to certain evidence) ended in favor of the plaintiff: Bard was ordered to pay $2 million in damages. The last two trials were settled before they went to court for an undisclosed amount.

The second round of Bard TVM cases is in case-specific discovery, and 200 lawsuits may be ready for trial by 2015. As well, a number of Avaulta lawsuits are pending in state courts.

Ethicon (Johnson & Johnson) transvaginal mesh

Judge Carol Higbee on July 21, 2014 denied Ethicon’s motions for a new trial and judgment notwithstanding the verdict on July 15 (Gross v. Gynecare Inc., Atl-L-6966-10). The New Jersey Superior Court judge, who is overseeing thousands of Ethicon transvaginal mesh lawsuits, upheld the $11.1 verdict awarded Linda Gross last year.

Almost 6,000 TVM lawsuits have been filed in an MDL which is underway in Atlantic County Superior Court. The first bellwether trial (March 2013) involving Ethicon’s Gynecare Prolift transvaginal mesh resulted in the jury awarding $3.35 million in compensatory damages and $7.76 million in punitive damages to a woman who suffered serious vaginal mesh complications. Ethicon is also facing more than 19,000 vaginal mesh lawsuits in a federal MDL underway in U.S. District Court, Southern District of West Virginia, according to court documents. (In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2327). A pretrial conference is slated for August 7, and jury selection will begin on August 22. Opening statements in the trial are scheduled to commence on August 25.

Boston Scientific transvaginal mesh

As of May 7, 2014, there were over 20,000 Boston Scientific transvaginal mesh product liability cases or claims pending in both federal and state courts nationwide, including eight putative class actions. There are more than 10 Boston Scientific cases pending in Canada and three in the UK. The federal cases have been consolidated in the U.S. District Court for the Southern District of West Virginia, (MDL 2326). More than 1,700 Boston Scientific TVM cases have been assigned to one judge in state court in Massachusetts.

According to Boston Scientific, the plaintiffs assert design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.

Additionally, in its fourth quarter report 2013, the company stated:

“The company received written discovery requests from certain state attorneys general offices. The company responded to those requests. The company established a product liability accrual for known and estimated future cases and claims asserted against the company as well as costs of defense thereof associated with our transvaginal surgical mesh products."

Transvaginal mesh and the FDA

In July 2014, the FDA refused to ban US sales of transvaginal mesh products, despite a 2011 citizen petition filed by Public Citizen’s Health Research Group. The public advocacy group had asked the FDA to recall and discontinue selling all transvaginal mesh products used to treat pelvic organ prolapse repair, and to reclassify the products in Class III pre-market approval.

While the FDA rejected most of the petition, the agency is taking action to put the transvaginal mesh devices into a higher-risk category (from Class II to a Class III). A Class III category also requires device manufacturers to submit a pre-market approval application so the FDA may assess the effectiveness and safety of a device before it goes on the market.

Lastly, attorneys are still accepting transvaginal mesh claims. Women experiencing pelvic and abdominal pain, painful intercourse and other mesh complications such as mesh erosion, mesh protrusion, punctured bladder and bowel vessels, due to vaginal mesh products may be eligible for compensation.